Abstract

PURPOSE: To prospectively evaluate the efficacy and safety of RIRS, SWL and PCNL for lower calyceal stones sized 1-2 cm. MATERIALS AND METHODS: Patients with a single lower calyceal stone with an evidence of a CT diameter between 1 and 2 cm were enrolled in this multicenter, randomized, unblinded, clinical trial study. Patients were randomized into three groups: group A: SWL (194 pts); group B: RIRS (207 pts); group C: PCNL (181 pts). Patients were evaluated with KUB radiography (US for uric acid stones) at day 10 and a CT scan after 3 months. The CONSORT 2010 statement was adhered to where possible. The collected data were analyzed. RESULTS: The mean stone size was 13.78 mm in group A, 14.82 mm in group B and 15.23 mm in group C (p = 0.34). Group C compared to group B showed longer operative time [72.3 vs. 55.8 min (p = 0.082)], fluoroscopic time [175.6 vs. 31.8 min (p = 0.004)] and hospital stay [3.7 vs. 1.3 days (p = 0.039)]. The overall stone-free rate (SFR) was 61.8% for group A, 82.1% for group B and 87.3% for group C. The re-treatment rate was significantly higher in group A compared to the other two groups, 61.3% (p < 0.05). The auxiliary procedure rate was comparable for groups A and B and lower for group C (p < 0.05). The complication rate was 6.7, 14.5 and 19.3% for groups A, B and C, respectively. CONCLUSIONS: RIRS and PCNL were more effective than SWL to obtain a better SFR and less auxiliary and re-treatment rate in single lower calyceal stone with a CT diameter between 1 and 2 cm. RIRS compared to PCNL offers the best outcome in terms of procedure length, radiation exposure and hospital stay. ISRCTN 55546280.

Comments 1

In this randomized comparison between SWL, RIRS and PCNL for treatment of 10-20 mm large LC-stones, the authors not unexpectedly reported stone-free rates (SFR) that were lower after SWL than after RIRS and PCNL.
The authors’ definition of SFR, however, differs from that used conventionally, because in the SFR category were also included asymptomatic patients with fragment erience that when RIRS /PCNL are termed auxiliary procedures this means failure of the primary treatment modality. If, on the other hand, the outcome was determined before the use of auxiliary procedures this is not clearly stated in the manuscript.
Inclusion of results of stone analysis is appreciated, but it had been even better if a distinction also had been made between COM and COD. Another notation is that the number of stone analyses exceeds the number of patients for which final conclusions were made (636 vs. 582).
Although the outcome was more or less expected nothing is mentioned about the experience of the SWL operators, neither is anything mentioned about details of the SWL procedure, nor of kind of pain-treatment or type of lithotripter.

In this randomized comparison between SWL, RIRS and PCNL for treatment of 10-20 mm large LC-stones, the authors not unexpectedly reported stone-free rates (SFR) that were lower after SWL than after RIRS and PCNL.
The authors’ definition of SFR, however, differs from that used conventionally, because in the SFR category were also included asymptomatic patients with fragment erience that when RIRS /PCNL are termed auxiliary procedures this means failure of the primary treatment modality. If, on the other hand, the outcome was determined before the use of auxiliary procedures this is not clearly stated in the manuscript.
Inclusion of results of stone analysis is appreciated, but it had been even better if a distinction also had been made between COM and COD. Another notation is that the number of stone analyses exceeds the number of patients for which final conclusions were made (636 vs. 582).
Although the outcome was more or less expected nothing is mentioned about the experience of the SWL operators, neither is anything mentioned about details of the SWL procedure, nor of kind of pain-treatment or type of lithotripter.